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      <content styleCode="bold">ZIMECTERIN® GOLD<br/>(ivermectin 1.55% / praziquantel 7.75%) Paste</content>
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               <title>INDICATIONS: </title>
               <text>
                  <paragraph>Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. ZIMECTERIN<sup>®</sup> GOLD (ivermectin/praziquantel) Paste provides effective treatment and control of the following parasites in horses. <content styleCode="bold">Tapeworms</content> – <content styleCode="italics">Anoplocephala perfoliata</content>, <content styleCode="bold">Large Strongyles</content> (adults) – <content styleCode="italics">Strongylus vulgaris</content> (also early forms in blood vessels), <content styleCode="italics">S. edentatus</content> (also tissue stages), <content styleCode="italics">S. equinus</content>, <content styleCode="italics">Triodontophorus</content> spp. including <content styleCode="italics">T. brevicauda</content> and <content styleCode="italics">T. serratus</content> and <content styleCode="italics">Craterostomum acuticaudatum</content>; <content styleCode="bold">Small Strongyles</content> (adults, including those resistant to some benzimidazole class compounds) – <content styleCode="italics">Coronocyclus</content> spp. including <content styleCode="italics">C. coronatus, C. labiatus</content> and <content styleCode="italics">C. labratus, Cyathostomum</content> spp. including <content styleCode="italics">C. catinatum</content> and <content styleCode="italics">C. pateratum</content>, <content styleCode="italics">Cylicocyclus</content> spp. including <content styleCode="italics">C. insigne</content>, <content styleCode="italics">C. leptostomum</content>, <content styleCode="italics">C. nassatus</content>, and <content styleCode="italics">C. brevicapsulatus</content>, <content styleCode="italics">Cylicodontophorus</content> spp., <content styleCode="italics">Cylicostephanus</content> spp., including <content styleCode="italics">C. calicatus</content>, <content styleCode="italics">C. goldi, C. longibursatus</content> and <content styleCode="italics">C. minutus</content>, and <content styleCode="italics">Petrovinema poculatum</content>; <content styleCode="bold">Small Strongyles</content> – Fourth-stage larvae; <content styleCode="bold">Pinworms</content> (adults and fourth-stage larvae) – <content styleCode="italics">Oxyuris equi</content>; <content styleCode="bold">Ascarids</content> (adults and third- and fourth-stage larvae) – <content styleCode="italics">Parascaris equorum</content>; <content styleCode="bold">Hairworms</content> (adults) – <content styleCode="italics">Trichostrongylus axei</content>; <content styleCode="bold">Large-mouth Stomach Worms</content>  (adults) – <content styleCode="italics">Habronema muscae</content>; <content styleCode="bold">Bots</content> (oral and gastric stages) – <content styleCode="italics">Gasterophilus</content> spp. including <content styleCode="italics">G. intestinalis</content> and <content styleCode="italics">G. nasalis</content>; <content styleCode="bold">Lungworms</content> (adults and fourth-stage larvae) – <content styleCode="italics">Dictyocaulus arnfieldi</content>; <content styleCode="bold">Intestinal Threadworms</content> (adults) – <content styleCode="italics">Strongyloides westeri</content>; <content styleCode="bold">Summer Sores</content> caused by <content styleCode="italics">Habronema</content> and <content styleCode="italics">Draschia</content> spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, <content styleCode="italics">Onchocerca</content> sp.</paragraph>
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               <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE &amp; ADMINISTRATION SECTION"/>
               <title>DOSAGE: </title>
               <text>
                  <paragraph>This syringe contains sufficient paste to treat one 1250 lb horse at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) body weight and 454 mcg praziquantel per lb (1 mg/kg) body weight. Each weight marking on the syringe plunger delivers enough paste to treat 250 lb body weight.</paragraph>
                  <paragraph>Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.</paragraph>
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               <code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
               <title>PARASITE CONTROL PROGRAM: </title>
               <text>
                  <paragraph>All horses should be included in a regular parasite control program with particular attention being paid to mares, foals and yearlings. Foals should be treated initially at 2 months of age, and routine treatment repeated as appropriate. Consult your veterinarian for a control program to meet your specific needs.</paragraph>
                  <paragraph>ZIMECTERIN<sup>®</sup> GOLD Paste effectively controls gastrointestinal cestodes, nematodes and bots of horses. Regular treatment will reduce the chances of verminous arteritis caused by <content styleCode="italics">Strongylus vulgaris</content>.</paragraph>
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               <title>PRODUCT ADVANTAGES: Broad-spectrum Control </title>
               <text>
                  <paragraph>ZIMECTERIN<sup>®</sup> GOLD Paste kills important internal parasites, including tapeworms, bots and the arterial stages of <content styleCode="italics">S. vulgaris</content>, with a single dose. ZIMECTERIN<sup>®</sup> GOLD Paste is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.</paragraph>
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               <title>ANIMAL SAFETY: </title>
               <text>
                  <paragraph>ZIMECTERIN<sup>®</sup> GOLD Paste may be used in horses two months of age or older. ZIMECTERIN<sup>®</sup> GOLD Paste has not been tested in foals younger than two months of age, mares at or near the time of breeding, pregnant or lactating mares, and breeding stallions. ZIMECTERIN<sup>®</sup> GOLD Paste, when tested at 1, 3 and 5-times the maximum recommended dose every two weeks in 5-month old foals, and at 10-times the maximum recommended dose in a separate study, did not elicit any adverse clinical signs of toxicity. In a foal safety study in younger animals, ZIMECTERIN<sup>®</sup> GOLD Paste was found safe at up to 3-times the maximum recommended dose in 2-month old foals.</paragraph>
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               <title>ADMINISTRATION: </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">1) While holding plunger, turn the knurled ring on the plunger ¼ turn to the left and slide it so the side nearest the barrel is at the prescribed weight marking, aligning the arrow on the plunger with the notch on the ring, as shown in the pictogram.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">2) Lock the ring in place by making ¼ turn to the right. Ensure it is locked (it should no longer slide).</content>
                  </paragraph>
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                              <paragraph>3) Make sure that the horse's mouth contains no feed.<br/> 4) Remove the cover from the tip of the syringe.<br/> 5) Insert the syringe tip into the horse's mouth at the space between the teeth.<br/> 6) Depress the plunger as far as it will go, depositing paste on the back of the tongue.<br/> 7) Immediately raise the horse's head for a few seconds after dosing.</paragraph>
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               <code code="34071-1" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS SECTION"/>
               <title>WARNING: </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Do not use in horses intended for human consumption. </content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Not for use in humans. Keep this and all drugs out of reach of children.</content>
                  </paragraph>
                  <paragraph>Refrain from smoking and eating when handling. Wash hands after use. Avoid contact with eyes. The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain a SDS, contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251.</paragraph>
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               <code code="42232-9" codeSystem="2.16.840.1.113883.6.1" displayName="PRECAUTIONS SECTION"/>
               <title>PRECAUTIONS: </title>
               <text>
                  <paragraph>ZIMECTERIN<sup>®</sup> GOLD (ivermectin/praziquantel) Paste has been formulated specifically for use in horses <content styleCode="bold">only</content>. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.</paragraph>
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               <title>OTHER WARNINGS: </title>
               <text>
                  <paragraph>Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. </paragraph>
                  <paragraph>Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. </paragraph>
                  <paragraph>Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd/flock, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). </paragraph>
                  <paragraph>A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.</paragraph>
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               <title>Post-Approval Experience: </title>
               <text>
                  <paragraph>Although not all adverse reactions are reported, the following reactions are based on voluntary post-approval drug experience reporting. There have been rare reports of swelling and irritation of the mouth, lips, and tongue following administration of ZIMECTERIN® GOLD. These reactions have been transitory in nature</paragraph>
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               <code code="50742-6" codeSystem="2.16.840.1.113883.6.1" displayName="ENVIRONMENTAL WARNING SECTION"/>
               <title>Environmental Safety: </title>
               <text>
                  <paragraph>Ivermectin and excreted ivermectin residues may adversely affect aquatic organisms. Do not contaminate ground or surface water. Dispose of the syringe in an approved landfill or by incineration.</paragraph>
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               <code code="50744-2" codeSystem="2.16.840.1.113883.6.1" displayName="INFORMATION FOR OWNERS/CAREGIVERS SECTION"/>
               <title>Information For Horse Owners: </title>
               <text>
                  <paragraph>Swelling and itching reactions after treatment with ivermectin have occurred in horses carrying heavy infections of neck threadworm (<content styleCode="italics">Onchocerca</content> sp.) microfilariae. These reactions were most likely the result of microfilariae dying in large numbers. Symptomatic treatment may be advisable. Consult your veterinarian should any such reactions occur. Healing of summer sores involving extensive tissue changes may require other appropriate therapy in conjunction with treatment with ZIMECTERIN<sup>®</sup> GOLD Paste. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.</paragraph>
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               <title>STORAGE: </title>
               <text>
                  <paragraph>Store up to 86°F (30°C). Transient exposure to temperatures up to 104°F (40°C) is permitted.</paragraph>
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                  <paragraph>
                     <content styleCode="bold">Make every dose count.</content>
                     <br/>
                     <content styleCode="bold">See New Instructions.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">Product No. 60011</content>
                     </content>
                  </paragraph>
                  <paragraph>®<content styleCode="bold">ZIMECTERIN</content> is a registered trademark of the Boehringer Ingelheim Group.<br/>©2019 Boehringer Ingelheim Animal Health USA Inc. All rights reserved.</paragraph>
                  <paragraph>Marketed by: Boehringer Ingelheim Animal Health USA Inc. </paragraph>
                  <paragraph>Duluth, GA - 30096<br/>Made in Brazil</paragraph>
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                     <caption>SEALED FOR SECURITY. IF BROKEN, DO NOT ACCEPT. </caption>
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               <title>Principal Display Panel – 7.35 g Paste Syringe Carton </title>
               <text>
                  <paragraph>
                     <content styleCode="bold">Approved by FDA under NADA # 141-214</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">
                        <content styleCode="italics">ZIMECTERIN</content>
                     </content>
                     <sup>®</sup>
                     <content styleCode="bold">
                        <content styleCode="italics">GOLD</content>
                     </content>
                     <br/>
                     <content styleCode="bold">(ivermectin 1.55% / praziquantel 7.75%) Paste</content>
                  </paragraph>
                  <paragraph>REMOVES ROUNDWORMS, <content styleCode="bold">TAPEWORMS</content> AND BOTS WITH A SINGLE DOSE.<br/>FOR ORAL USE IN HORSES ONLY</paragraph>
                  <paragraph>
                     <content styleCode="bold">Make every dose count.</content>
                     <br/>
                     <content styleCode="bold">See New Instructions.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">CONTENTS WILL TREAT UP TO 1250 lb BODY WEIGHT.</content>
                  </paragraph>
                  <paragraph>
                     <content styleCode="bold">Net Wt. 0.26 oz (7.35g)</content>
                  </paragraph>
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               </text>
               <effectiveTime value="20201125"/>
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                     <text>Picture of 7.35 g syringe carton</text>
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                        <reference value="image-02.jpg"/>
                     </value>
                  </observationMedia>
               </component>
            </section>
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